Module: Formulation & Delivery of Biopharmaceuticals

Latest Module Specifications

Current Academic Year 2025 - 2026

Module Title	Formulation & Delivery of Biopharmaceuticals
Module Code	BTE1037 (ITS: BE586)
Faculty	Biotechnology	School	Science & Health
NFQ level	9	Credit Rating	5

Description

The aim of this module is to provide bioprocess engineering students with a critical overview of the challenges in administering biopharmaceuticals and strategies for overcoming the main delivery barriers. State of the art concepts for successful delivery of therapeutic peptides, proteins, nucleic acid-based drugs and vaccines will be described.

Learning Outcomes

1. Describe novel formulation approaches for peptide and protein injectables (e.g. PEGylation, glycoengineering, acylation, amino acid substitution, protein fusion)
2. Discuss various depot delivery systems for peptide and protein injectables (eg micro-and nanoparticulate systems, in situ depot-forming systems, implant systems)
3. Identify challenges and strategies associated with intranasal, pulmonary, buccal, oral and transdermal delivery of peptides/protein drugs
4. Demonstrate an understanding of how chemical vectors and viral technology can overcome anatomical and cellular barriers for delivery of nucleic acids
5. Critically evaluate lipid nanoparticles and polymer-based systems for delivery of peptides, proteins, nucleic acids
6. Explain the role of freeze-drying technology in drug delivery systems

*Type*	*Hours*	*Description*
Workload	Full time hours per semester
Assessment Feedback	16	Blended asynchronous and synchronous classes
Independent Study	109	Directed learning
Total Workload: 125

Section Breakdown
CRN	20118	Part of Term	Semester 2
Coursework	0%	Examination Weight	0%
Grade Scale	40PASS	Pass Both Elements	Y
Resit Category	RC1	Best Mark	N
Module Co-ordinator	Caroline Devery Geoghegan	Module Teacher	Brian Freeland, Damien King, David Collins, Denise Harold, Linda Holland, Paul Cahill, Paula Meleady

Type	Description	% of total	Assessment Date
Assessment Breakdown
Report(s)	A series of open-book reports prepared in response to tasks/questions assigned each week	100%	n/a

Reassessment Requirement Type
Resit arrangements are explained by the following categories; RC1: A resit is available for both^* components of the module. RC2: No resit is available for a 100% coursework module. RC3: No resit is available for the coursework component where there is a coursework and summative examination element. ^* ‘Both’ is used in the context of the module having a coursework/summative examination split; where the module is 100% coursework, there will also be a resit of the assessment

Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Formulation and Delivery
Novel formulation and delivery approaches for peptide and protein injectables

Novel non-injectable formulations
Novel non-injectable formulation of peptides and proteins for oral and pulmonary delivery

Delivery of nucleic acids
Chemical vectors and Viral technology for delivery of nucleic acids

Polymer-Based delivery systems; role of freeze-drying technology
Polymer-Based delivery systems for oral and pulmonary delivery of peptides/proteins/nucleic acids. Role of freeze drying technology in oral drug delivery systems.

Indicative Reading List

Books:

Sindelar, Robert D., editor; Meibohm, Bernd, editor; Crommelin, D. J. A. (Daan J. A) editor: 2013, Pharmaceutical Biotechnology: fundamentals and applications, 4th Edition, Informa, ISBN 978-1-46
Aulton: 2013, Aulton's pharmaceutics: the design and manufacture of medicines, 4th Edition, Churchill Livingstone, ISBN: 0702042
Lene Jorgensen (Editor), Hanne Morck Nielson (Co-Editor): 2009, Delivery Technologies for Biopharmaceuticals: Peptides, Proteins, Nucleic Acids and Vaccines, Wiley, 978-0-470-723

Articles:
None

Other Resources

None